(101 days)
The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes / oocytes from the body.
The Oocyte Retrieval Needle Sets are sterile, single patient use, disposable devices supporting obtaining female gametes/oocytes from the body. The Oocyte Retrieval Needle Sets are packaged in a commercially available, sterile barrier pouch.
This document describes a 510(k) premarket notification for Oocyte Retrieval Needle Sets. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not applicable to this type of regulatory submission.
The document explicitly states:
- "The technology of the device is the same as the predicate."
- "Concesses of the manufacturing processes of the InnTec, Inc. Oocyte Retrieval Needle Sets are the same as the predicate device. No new questions of safety or effectiveness are raised."
- "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
This indicates that the submission relies on the established safety and effectiveness of the predicate device, and no new studies were conducted to define or meet specific performance acceptance criteria for this particular device.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).